Good Practices in Production

Presented By

Md. Shariful Islam

Department of PharmacyInternational Islamic University Chittagong

Good Practices in Production: General

Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorizations, with the objective of obtaining products of the requisite quality.

Good Practices in Production: General

All handling of materials and products; receipt

cleaning

quarantine

sampling

storage

labeling

dispensing

processing

packaging

distribution

should be done in accordance with written procedures and recorded.

Good Practices in Production: General

Any deviation from instructions or procedures should be avoid as far as possible.

If deviations occur: should be done in accordance with an approved procedure

approved in writing by a designated person

Good Practices in Production: General

Checks on yields and reconciliation of quantities to ensure that there are no discrepancies outside acceptable limits.

Good Practices in Production: General

Operation on different products should not be carried out simultaneously or consecutively in the same room or area unless there is no risk of mix-up or cross-contamination.

Good Practices in Production: General

At all time during processing

all materials

bulk containers

major items of equipment

rooms

packaging lines

being used should be labeled or identified

Good Practices in Production: General

Access to production premises should be restricted to authorized personnel.

Non-medicinal products should not be produced in areas or with equipment destined for the production of pharmaceutical products.

Good Practices in Production: General

In-process controls are usually performed within the production area.

The performance should not have any negative effect on the quality of the product or another product.

Good practices in production: Prevention of cross-contamination during production

When dry materials and products are used in production, special precaution should be taken to prevent the generation and dissemination of dust.

proper air control e.g. supply and extraction of air of suitable quality

Good practices in production: Prevention of cross-contamination during production

Contamination of a starting material or of a product by another material or product must be avoid.

accidental cross-contamination arises from

uncontrolled release of dust, gases, particles, vapours. sprays or organisms from materials and products in process

residues on equipment

intruding insects

operators’ clothing, skin, etc.

most hazardous, highly sensitizing materials

living organisms, hormones, cytotoxic substances, and others

Good practices in production: Prevention of cross-contamination during production

Avoided by taking appropriate technical e.g.

carrying out production in dedicated and self-contained areas

conducting campaign production followed by appropriate cleaning in accordance with a validated cleaning procedure

providing appropriately designed airlocks, pressure differentials and air supply and extraction systems

Good practices in production: Prevention of cross-contamination during production

minimizing the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air

wearing protective clothing

using cleaning and decontamination procedures of known effectiveness

using a closed system in production

testing for residues

using cleanliness status labels on equipment

Good practices in production: Prevention of cross-contamination during production

Measures to prevent cross-contamination and their effectiveness should be checked periodically according to SOP.

Production areas periodic

environmental monitoring

Good practices in production: Processing operations

Before any processing operation

work area and equipment

clean and free from any starting materials, products, product residues, labels or documents not required for the current operation.

Good practices in production: Processing operations

Any necessary in-process controls and environmental controls should be carried out and recorded

Indicate the failures of equipment or services (e.g. water, gas) to equipment

defective EQ withdrawn

after use, production EQ

cleaned without delay,

stored under clean and dry conditions in separate area

Good practices in production: Processing operations

Time limits for storage of EQ after cleaning and before use

Containers for filling should be cleaned before filling

Any significant deviation from the expected yield

recorded and investigated

Good practices in production: Processing operations

Checks

pipelines and other pieces of EQ used for transportation of products

Pipe used for conveying distilled or deionized water

sanitized and stored according to written procedures (action limits for microbiological contamination and measures

Good practices in production: Processing operations

EQ and instruments

serviced and calibrated at prespecified interval

records maintained

checked daily or prior to use

clearly indicated the date of calibration and servicing, recalibration (label attached to instrument)

Repair and maintenance operations

not present any hazard to the quality of the products